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We proposed at 428.401 the use of an initial Preliminary Rebate Report and a subsequent Rebate Report, with an ( opportunity for manufacturers to identify certain mathematical errors (see 428.403 and discussed in further detail later in this section) and two regular reconciliations of the rebate amount to account for updates to claims and payment data at 12 months and 36 months after the Rebate Report is issued as set forth in 428.401(d)

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We note that these medical services include either modality of dialysis that a beneficiary is receiving, ( hemodialysis or peritoneal dialysisand whether or not it is administered in the home or in-center at an ESRD facility

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In addition, a wide array of interested parties recommended that CMS create a mechanism through which covered entities would retrospectively submit data to CMS identifying 340B claims dispensed under Part D